Panel Tells FDA to Postpone ADHD Drug Labeling Changes

AUGUST 01, 2005

Members of the Pediatric Advisory Committee recently informed the FDA that it was hesitant to recommend a label change for a class of stimulants used to treat attentiondeficit/ hyperactivity disorder (ADHD), according to a press release posted on the FDA Web site. The committee reported that it did not come across any new concerns about psychiatric side effects with Concerta and other methylphenidates, such as Ritalin and Metadate. The panel also recommended that the FDA wait until more safety data have been collected on 2 other types of drugs for ADHD—methamphetamines, such as Adderall, and the nonstimulant atomoxetine HCl (Strattera).

Reports of psychiatric events and possible cardiovascular side effects prompted the FDA to consider labeling changes to all methylphenidates. A review found 36 psychiatric events for Concerta, compared with 16 for Ritalin and other methylphenidates. Concerta had 20 cardiovascular events, compared with 4 reports with other methylphenidates.

Although the committee recommended delaying labeling changes, Dianne Murphy, MD, director of the Office of Pediatric Therapeutics, said the FDA may still move forward with the change regarding psychiatric side effects to "try and make it clearer what the situation is with regard to certain adverse events."